Formatech offers the following support services to our CGMP aseptic manufacturing facility. From product development to clinical supply manufacturing, we strive to streamline the process to the clinical. Some of our support services include:
Quality Assurance:
- Material Handling systems
- Documentation control
- Equipment and Utilities
- Personnel training programs
- Stability programs
Manufacturing Support Services:
- Technology transfer and scale up of manufacturing processes
- Diafiltration/concentration
- Lyophilization development and cycle optimization
- Labeling and packaging
- Analytical support including methods development of release assays and validation
- Batch record development/documentation
